Cellular Biomedicine Group announced early data from its ongoing investigator initiated trial (at an oral presentation titled "Novel Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma" at the American Society of Hematology annual meeting. A Phase 1, dose escalation trial is being conducted in patients with relapsed or refractory multiple myeloma to assess the safety and efficacy of C-CAR088. As of the end of November the company has enrolled eleven patients, of which eight were infused with C-CAR088, and five patients were evaluable for clinical response. Three of the five patients were treated with C-CAR088 at the dose of 1.0 x 106 CAR-T cells/kg, and the other two patients treated at 3.0x106 CAR-T cells/kg. All five patients showed clinical improvement as early as two weeks post treatment, Cellular Biomedicine said in a statement. By four weeks, one patient achieved a complete response, three patients reached a very good partial response, and one patient reached a partial response post C-CAR088 infusion, the company said. Furthermore, Cellular Biomedicine observed that C-CAR088 proliferation and expansion in the peripheral blood correlated with the decrease of tumor burden in all patients. C-CAR088 treatment showed to be well tolerated, it added.

AbbVie announced results from an extended follow-up analysis of the Phase 3 E1912 clinical study - designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute. Study results showed superior progression-free survival and overall survival in patients with chronic lymphocytic leukemia new to treatment, the company said. These results demonstrated the benefits of Imbruvica plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab for previously untreated patients with chronic lymphocytic leukemia aged 70 years or younger. Additionally, a new integrated analysis of up to six years of long-term follow-up from the Phase 3 Resonate and Resonate-2 studies will be presented on December 8 at the American Society of Hematology Annual Meeting, evaluating the use of Imbruvica monotherapy in previously untreated patients. Results showed better progression-free survival, overall survival and overall response rate, with good tolerability compared to use in the relapsed/refractory setting, according to AbbVie. At a median follow-up of 48 months, 73% of patients in the Imbruvica plus rituximab treatment arm remained on Imbruvica with median time on treatment of 43 months. The median time to progression or death after discontinuing Imbruvica was 23 months.

Janssen Pharmaceutical Companies of Johnson & Johnson announced initial results from the Phase 1b/2 Cartitude-1 study evaluating the efficacy and safety of JNJ-68284528, an investigational B cell maturation antigen-directed chimeric antigen receptor T cell therapy being evaluated in the treatment of patients with relapsed or refractory multiple myeloma. The study enrolled patients who have received at least three prior lines of therapy or are double refractory to a proteasome inhibitor and an immunomodulatory drug; have received a PI, IMiD and an anti-CD38 antibody; and who progressed on or within 12 months of their last line of therapy. Results from the Phase 1b portion of the study showed "early and deep responses" among 29 patients with a median of five prior multiple myeloma treatment regimens treated with JNJ-4528, with 100% of patients achieving a response at a median six-month follow-up, Janssen said. The overall response rate included 69% of patients achieving a complete response or better; 86% of patients achieving a very good partial response or better; and 14% of patients achieving a partial response. In addition, 100% of evaluable patients achieved early minimal residual disease-negative disease status at day 28 post-infusion. At the six-month follow-up, 27 of 29 patients were progression-free. Based on the Phase 1b results, a recommended Phase 2 dose of 0.75x106 CAR+ viable T cells/kg was confirmed, the company added. The most common adverse events observed in the study were cytokine release syndrome, neutropenia, anemia and thrombocytopenia.